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Memantine Treatment in Patients with Mild to Moderate Alzheimers Disease Already Receiving a Cholinesterase Inhibitor: A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
OBJECTIVE: To evaluate the efficacy and safety of memantine in patients with mild to moderate Alzheimer's disease (AD) receiving cholinesterase inhibitor (ChEI) treatment. METHODS: Participants (N= 433) with probable AD, Mini-Mental State Exam (MMSE) scores between 10-22 (inclusive), and concurrent stable use of ChEIs (donepezil, rivastigmine, galantamine) were randomized to placebo or memantine (20 mg once daily) for 24 weeks. Primary outcomes were changes from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) score. Secondary measures comprised the 23-item Alzheimer Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL(23)), Neuropsychiatric Inventory (NPI), and MMSE. RESULTS: At the end of the trial, there were no statistically significant differences between the memantine- and placebo group on primary and secondary outcome measures. The incidence of adverse events (AEs) was similar between the two groups, with no AE occurring in more than 5% of memantine-treated patients and at a rate twice that of the placebo group. CONCLUSIONS: In this trial, memantine did not show an advantage over placebo based on protocol-specified primary or secondary analyses in patients with mild to moderate AD on stable ChEI regimens. There were no significant differences in tolerability and safety between the memantine- and placebo groups.
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“Short-term (6-12 months) RCTs (level I evidence), longer-term (12-36 months) openlabel extensions of RCTs (level II or III evidence), and long-term (2 to 5-plus years) observational prospective clinical cohort effectiveness studies (level II evidence) support the safety and benefits of anti-AD treatments in combination, most frequently as memantine added on to a stable regimen of background ChEI”
From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [121]
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BackgroundChen, Z., & Zhong, C. (2013) · Progress in Neurobiology · doi:10.1016/j.pneurobio.2013.06.004 · Cited by 698
“The short-term efficacy of complement of memantine to ChEIs treatment has been evaluated in some randomized controlled trials (Beier, 2004; Porsteinsson et al., 2008), one of them showed significant benefits of adding memantine verse placebo; but another trial failed.”
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“Although there is controversy over the entity of the advantage, there is good agreement among studies showing that memantine can be safely combined with cholinesterase inhibitors.(252) As for cholinesterase inhibitors, there is currently no evidence that memantine alters the accumulation of Abeta and tau protein patho…”
ResultMemantine for Alzheimer’s Disease: An Updated Systematic Review and Meta-analysis
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“However, the thera- peutic benefits of memantine in AD have been limited (for example, Porsteinsson et al. 2008), and this drug may not block the primary upstream mechanisms by which Ab elicits aberrant excitatory neuronal activity.”
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“However, a more recent study investigating memantine add-on to all three cholinesterase inhibitors failed to demonstrate any clear cognitive or non-cognitive benefit (Porsteinsson et al., 2008).”
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“The NPI has been widely used for quantifying neuropsychiatric symptoms in AD in observational studies (Palmer et al., 2010) and in recent clinical trials (Porsteinsson et al., 2008).”
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“However, in an RCT of patients with mild-to-moderate disease, addition of memantine did not confer an advantage over ChEI monotherapy [41].”
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Self-citationMemantine in dementia: a review of the current evidence
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“There is evidence that memantine is effective and cost-saving in moderate and severe AD (Areosa et al., 2005; Wimo et al., 2003), but it is not clear whether memantine in combination with an AChE inhibitor confers additional clinical benefits (Tariot et al., 2004; Porsteinsson et al., 2008).”
BackgroundPharmacological and Nonpharmacological Treatment for Apathy in Alzheimer Disease
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“were combined with those of patients from the three memantine trials in mild to moderate AD [”
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“Memantine, an uncompetitive NMDA receptor antagonist, has been shown in clinical trials to be beneficial in patients with moderate to severe AD (Reisberg et al., 2003, 2006; Porsteinsson et al., 2008; Wang et al., 2013).”
BackgroundVitamin E and memantine in Alzheimer's disease: Clinical trial methods and baseline data
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Effectiveness and Safety of Memantine Treatment for Alzheimer's Disease
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“[ 35 ] R C T, m em an tin e”
Antidementia drug use among community-dwelling individuals with Alzheimer’s disease in Finland
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“Effectiveness and tolerability of concomitant use has been reported in the literature but is still under debate (Atri et al., 2008; Porsteinsson et al., 2008; Lopez et al., 2009).”
BackgroundA combination of galantamine and memantine modifies cognitive function in subjects with amnestic MCI
Peters, O., Lorenz, D., Fesche, A., Schmidtke, K., Hüll, M., Perneczky, R., Rüther, E., Möller, H. ‐., Jessen, F., Maier, W., et al. (2012) · The journal of nutrition health & aging · doi:10.1007/s12603-012-0062-8 · Cited by 55
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TREATMENT OF COGNITIVE DEFICITS IN ALZHEIMER'S DISEASE: A PSYCHOPHARMACOLOGICAL REVIEW
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Alzheimer's Therapeutics: Translation of Preclinical Science to Clinical Drug Development
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“However, another study demonstrated no additional benefits from combination therapy (Porsteinsson et al, 2008; see also Schneider et al, 2011).”
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“Acetylcholinesterase inhibitors (Birks and Grimley Evans, 2015) and memantine (Porsteinsson et al., 2008) are used to provide symptom relief.”
Background
Metadata
- Authors
- Porsteinsson, A., Grossberg, G., Mintzer, J., & Olin, J.
- Affiliations
- University of Rochester Medicine (US)
- Venue
- Current Alzheimer Research
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2008-02-01
- Volume
- 5
- Issue
- 1
- Pages
- 83-89
- ISSN
- 1567-2050 (ISSN-L)
- OpenAlex
- W2149626554
- Cited by
- 272
- References
- 0
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 8 · 2023: 7 · 2022: 13 · 2021: 9 · 2020: 8 · 2019: 17 · 2018: 9 · 2017: 12 · 2016: 16 · 2015: 21 · 2014: 17 · 2013: 22 · 2012: 28
- FWCI
- 17.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Alzheimer Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Keywords
- memantine, Alzheimer's disease, cholinesterase inhibitors, donepezil, rivastigmine, galantamine, combination therapy, cognitive function, activities of daily living, neuropsychiatric symptoms, drug safety, tolerability
- MeSH terms
- Activities of Daily Living, Aged, Aged, 80 and over, Alzheimer Disease, Cholinesterase Inhibitors, Double-Blind Method, Drug Therapy, Combination, Humans, Memantine, Mental Status Schedule, Middle Aged, Neuropsychological Tests, Prospective Studies, Severity of Illness Index, Receptors, N-Methyl-D-Aspartate, Treatment Outcome, Excitatory Amino Acid Antagonists
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